Company to file IND with FDA and plans to commence trial in 2016
RAANANA, Israel I March 21, 2016 I XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or the “Company”), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today announced it has completed the clinical trial design for its upcoming Phase 2 study of hCDR1 in the treatment of systemic lupus erythematosus (SLE). The global study is planned to commence in 2016, following the Company’s investigational new drug (IND) filing with the U.S. Food and Drug Administration (FDA).
The study, developed in consultation with XTL’s Clinical Advisory Board, is based on encouraging feedback received from the FDA in response to the Company’s pre-IND meeting package.
The planned global Phase 2 trial is a double-blind, placebo controlled 26 week study to evaluate the safety and efficacy of hCDR1 in the treatment of SLE. The study will include three arms. Two arms will treat subjects with a different hCDR1 weekly dose, one of which will be the 0.5 mg dose which was the most effective dose tested in the previous Phase 2 study, and the third arm will be placebo. The primary efficacy endpoint of the study will be the proportion of subjects achieving a favorable response at 26 weeks in at least one organ system. BILAG is a standard diagnostic measure of the severity of lupus in organ systems and the recommended measure for efficacy for our trial by the FDA. Data from a prior Phase 2 study clearly showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index.
Secondary endpoints include proportions of patients achieving a substantial response by BILAG 2004, proportion of patients achieving a response by SLEDAI-2K Responder Index 50, and additional endpoints presented and accepted by the FDA. Steroid dosing of subjects will be restricted to improve patient outcomes. Prior studies showed that reduced steroid usage corresponded with improved efficacy in patients treated with hCDR1.
“We worked closely with the world-renowned lupus experts on our Clinical Advisory Board to develop this study design based on the BILAG index as a measure of hCDR1’s efficacy. The FDA’s recent guidance indicating that BILAG is an appropriate efficacy endpoint for our trial was a very significant and positive milestone. It enabled us to optimize our study design, and in our opinion, improves the likelihood of the study’s success based on the efficacy results of the prior Phase 2 trial when a 0.5 mg dose of hCDR1 was used with the BILAG index,” said Josh Levine, CEO of XTL. “We look forward to filing our IND in the U.S. and commencing the trial this year.”
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and has clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The biologic basis of the disease is a defect in the immune (defense) system, leading to production of self (auto) antibodies, attacking the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least 1.5 million Americans have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The majority of patients are women of childbearing years. There has been only one drug approved by the FDA in the last 50 years and recently two of the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of systemic lupus erythematosus (SLE). Treatments currently on the market for SLE are not effective enough for most patients and some have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals. Based on encouraging safety and efficacy data shown in a completed Phase 2 study, the Company expects to initiate a Phase 2 trial in 2016.
SOURCE: XTL Biopharmaceuticals
Post Views: 131
Company to file IND with FDA and plans to commence trial in 2016
RAANANA, Israel I March 21, 2016 I XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or the “Company”), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today announced it has completed the clinical trial design for its upcoming Phase 2 study of hCDR1 in the treatment of systemic lupus erythematosus (SLE). The global study is planned to commence in 2016, following the Company’s investigational new drug (IND) filing with the U.S. Food and Drug Administration (FDA).
The study, developed in consultation with XTL’s Clinical Advisory Board, is based on encouraging feedback received from the FDA in response to the Company’s pre-IND meeting package.
The planned global Phase 2 trial is a double-blind, placebo controlled 26 week study to evaluate the safety and efficacy of hCDR1 in the treatment of SLE. The study will include three arms. Two arms will treat subjects with a different hCDR1 weekly dose, one of which will be the 0.5 mg dose which was the most effective dose tested in the previous Phase 2 study, and the third arm will be placebo. The primary efficacy endpoint of the study will be the proportion of subjects achieving a favorable response at 26 weeks in at least one organ system. BILAG is a standard diagnostic measure of the severity of lupus in organ systems and the recommended measure for efficacy for our trial by the FDA. Data from a prior Phase 2 study clearly showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index.
Secondary endpoints include proportions of patients achieving a substantial response by BILAG 2004, proportion of patients achieving a response by SLEDAI-2K Responder Index 50, and additional endpoints presented and accepted by the FDA. Steroid dosing of subjects will be restricted to improve patient outcomes. Prior studies showed that reduced steroid usage corresponded with improved efficacy in patients treated with hCDR1.
“We worked closely with the world-renowned lupus experts on our Clinical Advisory Board to develop this study design based on the BILAG index as a measure of hCDR1’s efficacy. The FDA’s recent guidance indicating that BILAG is an appropriate efficacy endpoint for our trial was a very significant and positive milestone. It enabled us to optimize our study design, and in our opinion, improves the likelihood of the study’s success based on the efficacy results of the prior Phase 2 trial when a 0.5 mg dose of hCDR1 was used with the BILAG index,” said Josh Levine, CEO of XTL. “We look forward to filing our IND in the U.S. and commencing the trial this year.”
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and has clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The biologic basis of the disease is a defect in the immune (defense) system, leading to production of self (auto) antibodies, attacking the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least 1.5 million Americans have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The majority of patients are women of childbearing years. There has been only one drug approved by the FDA in the last 50 years and recently two of the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of systemic lupus erythematosus (SLE). Treatments currently on the market for SLE are not effective enough for most patients and some have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals. Based on encouraging safety and efficacy data shown in a completed Phase 2 study, the Company expects to initiate a Phase 2 trial in 2016.
SOURCE: XTL Biopharmaceuticals
Post Views: 131
